TRIDERMA STUBBORN DIAPER RASH RELIEF- allantoin, dimethicone cream

TriDerma Stubborn Diaper Rash Relief by

Drug Labeling and Warnings

TriDerma Stubborn Diaper Rash Relief by is a Otc medication manufactured, distributed, or labeled by Genuine Virgin Aloe Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Allantoin 1.5%
Dimethicone 2.0%

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses Helps treat and prevent diaper rash Helps seal out wetness Temporarily protects and helps relieve chafed, chapped or cracked skin

WARNINGS

Warnings For external use only

Do not use on deep puncture wounds on infections on lacerations.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if condition worsens or does not improve within 7 days.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions Change wet/soiled diapers promptly. Cleanse diaper area and allow to dry. Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged.

STORAGE AND HANDLING

Other information Store at room temperature Keep carton for important information.

INACTIVE INGREDIENT

Inactive ingredients: water, butyrospermum parkii (shea) butter, glycerin, glyceryl stearate SE, cera alba (beeswax), cetearyl alcohol, carthamus tinctorius (safflower) seed oil, avena sativa (oat) kernel flour, polysorbate 60, polysorbate 80, cetyl esters, zinc PCA, sodium PCA, aloe barbadensis leaf juice*, panthenol (pro-vitamin B5), tocopheryl acetate (vitamin E), glyceryl stearate, sorbic acid, sodium hyaluronate, sodium phytate, sodium hydroxide, cetyl potassium phosphate, xanthan gum, phenoxyethanol, ethylhexylglycerin. *Certified Organic Ingredient - Mayacert Certifier

QUESTIONS

Questions? 1-800-279-7282 M-F 8am-4pm PST

SPL UNCLASSIFIED SECTION

Helps treat & prevent diaper rash

Helps seal out wetness

Dermatologist Tested

This maximum strength cream works quickly to help relieve everyday or hard-to-heal, stubborn diaper rash.

Stubborn diaper rash can be result of changes in diet, medication, or prolonged wetness.

Made with essential botanicals, vitamins, AP4® Organic Aloe* Complex and clinically proven skin protectants, this soothing cream helps promote healing after the 1st use.

AP4® Organic Aloe* Complex - proprietary soothing botanical blend

Colloidal Oats - helps soothe & relieve irritated skin

Shea Butter - soothes & moisturizes

Beeswax - calming properties

Zinc PCA - additional healing

Also try:

Stubborn Eczema Itch™ Relief Cream

Aloe Healing & Cleansing Gel™

Daily Calming™ Moisturizer

Maximum Strength
Healing Botanicals

Stubborn Diaper Rash™ Relief Cream contains more healing power and is less sticky/gooey than most traditional diaper rash creams.

Works quickly
Soothes tender skin
Helps prevent diaper rash from recurring

Non-Greasy No Added Fragrance
Free from Cortisone, Steroids & Parabens

EXPERTS IN SKIN HEALING SINCE 1992

TriDerma MD® provides healing solutions for irritated skin without harmful side effects.

It all began after one woman struggled to find safe and effective healing for her own skin problem.

This journey led to the creation of our proprietary AP4® Organic Aloe* Complex which is key to all our products.

QUALITY YOU CAN FEEL, RESULTS YOU CAN SEE.®

Each product is made using this powerful complex plus nature’s best botanicals and clinically proven ingredients.

We are passionate in our pursuit to create fast healing products that work.

Learn More at www.triderma.com

MADE IN THE USA

Dist. by: Genuine Virgin Aloe Corp., Corona, CA 92879 ©2019 0919

Packaging

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INGREDIENTS AND APPEARANCE

TRIDERMA STUBBORN DIAPER RASH RELIEF 
allantoin, dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10738-068
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	1.5 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
WHITE WAX (UNII: 7G1J5DA97F)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SAFFLOWER OIL (UNII: 65UEH262IS)
OATMEAL (UNII: 8PI54V663Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CETYL ESTERS WAX (UNII: D072FFP9GU)
ZINC PIDOLATE (UNII: C32PQ86DH4)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SORBIC ACID (UNII: X045WJ989B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PHYTATE SODIUM (UNII: 88496G1ERL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM PHOSPHATE, TRIBASIC (UNII: 16D59922JU)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10738-068-50	1 in 1 CARTON	10/31/2019
1	NDC: 10738-068-55	14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10738-068-20	1 in 1 CARTON	10/31/2019
2	NDC: 10738-068-25	62 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 10738-068-40	1 in 1 CARTON	10/31/2019
3	NDC: 10738-068-45	113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/31/2019

Labeler - Genuine Virgin Aloe Corporation (961374147)

Establishment
Name	Address	ID/FEI	Business Operations
Genuine Virgin Aloe Corporation		961374147	manufacture(10738-068)